Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- The incidence of adverse events and serious adverse events
Study Overview
Brief Summary
Narcolepsy type 1 (NT1) is a chronic brain disorder caused by selective loss or dysfunction of orexin (hypocretin) neurons in the lateral hypothalamus, for which current pharmacological treatments offer limited efficacy. Temporal interference (TI) stimulation is a recently developed noninvasive neuromodulation technique that enables focal modulation of deep brain structures. In this randomized, double-blind study, we developed a theta-burst patterned TI protocol and evaluated its effects in patients with NT1.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 12 to 60 years.
- •Diagnosis of narcolepsy type 1 according to the International Classification of Sleep Disorders, Third Edition (ICSD-3), confirmed by polysomnography (PSG) and/or Multiple Sleep Latency Test (MSLT) performed within the past 10 years, with the test procedures meeting the minimum technical standards specified in the ICSD-
- •Epworth Sleepiness Scale score >12 at baseline.
- •Signed informed consent.
Exclusion Criteria
- •Presence of other conditions that cause excessive daytime sleepiness, including restless legs syndrome, periodic limb movement disorder, or moderate-to-severe obstructive sleep apnea syndrome, etc.
- •History of epilepsy, severe neuropsychiatric disorders, or significant cardiac, hepatic, or renal dysfunction.
- •Pregnancy or current breastfeeding.
- •Contraindications to MRI or electrical stimulation therapy, such as intracranial metallic foreign bodies, cardiac pacemakers, implantable cardioverter-defibrillators, or cochlear implants.
Arms & Interventions
Sham TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks. Each session is scheduled for 40 minutes, but actual current is delivered only as a short 30-second pulse at the start and at the end, with no current applied in between.
Intervention: Sham Temporal Interference Stimulation (Device)
Active TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks. The current will be applied for 40 minutes per session.
Intervention: Active Temporal Interference Stimulation (Device)
Outcomes
Primary Outcomes
The incidence of adverse events and serious adverse events
Time Frame: Baseline, 2-week treatment period, 4-week follow-up period
Change from baseline to week 2 in mean sleep latency from the MWT
Time Frame: Baseline, Week 2
Secondary Outcomes
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency(Weeks 1, 2, 3 and 4 following treatment)
- Change from baseline to week 2 in Epworth Sleepiness Scale total score(Baseline, Week 2)
- Change from baseline to week 2 in Narcolepsy Severity Scale score(Baseline, Week 2)
- Change from baseline to week 2 in weekly cataplexy frequency(Baseline, Week 2)
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score(Weeks 1, 2, 3, and 4 following treatment)
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score(Weeks 1, 2, 3 and 4 following treatment)